MAUDE Adverse Event Report: ARTHREX INC. CANNULATED DELTA TAPERED BIO-INTERFERENCE SCREW, 7.5 MM - 9 MM X 35 MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	AR-5035TB-09
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device is expected but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during surgery, the tip of the screw broke inside the drill hole.The device could not be retrieved and will remain inside the patient.No further details given.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is a follow-up submission due to device evaluation.Complaint confirmed.The evaluation revealed that the screw's tip was broken-off.The device met all material specifications as received.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging, improper bone preparation or flexing the joint during insertion.Product directions for use (b)(4) informs users to "insert the screwdriver into the screw to a fully seated position.Failure to engage the screw completely may result in damage to the implant.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during surgery, the tip of the screw broke inside the drill hole.The device could not be retrieved and will remain inside the patient.No further details given.

• Brand Name: CANNULATED DELTA TAPERED BIO-INTERFERENCE SCREW, 7.5 MM - 9 MM X 35 MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6913260
• Report Number: 1220246-2017-00360
• Device Sequence Number: 11123620
• Product Code: MAI
• UDI-Device Identifier: 00888867035461
• UDI-Public: 00888867035461
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: AR-5035TB-09
• Device Catalogue Number: AR-5035TB-09
• Device Lot Number: 10105338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 10/04/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other